Good Manufacturing Practice (GMP) for Medicinal Products requires batch release against the approved product specification.
Our laboratories utilise a wide range of pharmacopoeial or client specific methods to provide reliable confirmation that products meet their specification. Routine handling of various sample matrices makes ALS well positioned to meet the needs of our clients' ever expanding product portfolios and diverse product ranges.
Examples of routinely handled sample matrices include:
- Tablets
- Syrups
- Creams, Ointments & Gels
- Oral and topical liquids
- Capsules
- Powders and granules
Both chemical and microbiology testing services are offered:
- Assays
- Disintegration
- Dissolution
- Dimensions and Hardness of tablets
- HPLC - UV, RI, DAD detectors
- Gas Chromatography FID and Headspace
- Ion Chromatography
- Compendial analysis (BP, EP, JP and USP etc.)
- Complete microbiological testing including total viable counts (TVC) and pathogens, microbial identification, preservative efficacy testing (PET), bacterial endotoxin (LAL) testing
- Elemental Impurities by USP <233> using ICP-MS
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